Market Newsdesk

LA JOLLA, Calif., Jan. 5, 2021 /PRNewswire/ — Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs (“Regulus”), today announced that Jay Hagan, President and Chief Executive Officer of Regulus, will present at the H.C. Wainwright Virtual BioConnect Conference being held from January 11-14, 2021.

A webcast of the on-demand presentation will be available beginning Monday, January 11, 2021 through the investor relations section of the Company’s website at www.regulusrx.com.

About Regulus

Regulus Therapeutics Inc. (Nasdaq: RGLS) is a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs. Regulus has leveraged its oligonucleotide drug discovery and development expertise to develop a pipeline complemented by a rich intellectual property estate in the microRNA field. Regulus maintains its corporate headquarters in La Jolla, CA.

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995.  Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “intends,” “will,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Regulus’ current expectations and involve assumptions that may never materialize or may prove to be incorrect.  Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics and in the endeavor of building a business around such drugs, and feedback from the FDA. In addition, while Regulus expects the COVID-19 pandemic to adversely affect its business operations and financial results, the extent of the impact on Regulus’ ability to achieve its preclinical and clinical development objectives and the value of and market for its common stock, will depend on future developments that are highly uncertain and cannot be predicted with confidence at this time, such as the ultimate duration of the pandemic, travel restrictions, quarantines, social distancing and business closure requirements in the U.S. and in other countries, and the effectiveness of actions taken globally to contain and treat the disease.   These and other risks are described in additional detail in Regulus’ filings with the Securities and Exchange Commission.  All forward-looking statements contained in this press release speak only as of the date on which they were made. Regulus undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

View original content to download multimedia:http://www.prnewswire.com/news-releases/regulus-therapeutics-to-present-at-the-hc-wainwright-virtual-bioconnect-conference-301200819.html

SOURCE Regulus Therapeutics Inc.

SECAUCUS, N.J., Jan. 5, 2021 /PRNewswire/ — The Vitamin Shoppe®, an omni-channel specialty retailer of nutritional products, today announced a new partnership with WW International, Inc. (NASDAQ: WW), a global wellness company powered by the world’s leading commercial weight management program, to amplify their shared mission to empower and support people on their health and wellness journeys.

The Vitamin Shoppe and WW collaboration includes a variety of integrated offerings and livable solutions to inspire healthy habits, such as the launch of co-branded nutritional supplements; the introduction of select member-favorite WW snacks and protein boosters to The Vitamin Shoppe; as well as the opportunity to purchase WW memberships through The Vitamin Shoppe. All products are available for purchase at The Vitamin Shoppe and Super Supplements’ more than 715 retail locations nationwide, on vitaminshoppe.com/ww, on ww.com/shop and in WW Studios. WW members can also redeem gift cards to The Vitamin Shoppe through the WW WellnessWins™ rewards program. 

This collaboration brings together two leaders in health and wellness at a time when people are looking for guidance as they kick-start their 2021 health and wellness goals. According to a new study conducted by OnePoll on behalf of The Vitamin Shoppe and WW, while 92% of Americans agree that 2020 allowed them to improve some aspects of their health and wellness, 63% say they will need support and help to reach their 2021 goals.

Sharon Leite, CEO of The Vitamin Shoppe, commented: “We have seen numerous trends showing that health and wellness have become a top priority for Americans, with consumers actively seeking out the most trusted resources for products and services. This partnership represents a momentous opportunity to provide comprehensive health and nutrition support, from easy-to-use daily supplements to healthier snack and protein choices, in addition to access to WW’s highly effective and personalized wellness offering in all of our stores. We are excited to begin this partnership that brings two of the most innovative, customer-centric companies together to deliver holistic wellness solutions to a broad audience.”

Designed to provide people with key nutrients that may be lacking in their day-to-day eating pattern¹ — and developed with the industry-leading quality standards of The Vitamin Shoppe — the two co-branded nutritional supplement packs available in-store and online through The Vitamin Shoppe and WW include:

• WW by the Vitamin Shoppe Daily Essentials: This daily pack features essential vitamins, minerals, and nutrients, including vitamin C, magnesium, omega-3, and L-theanine. It helps fill nutrient gaps that play a role in whole-body health, including immunity and bone, heart, brain, skin, and eye health ($29.99 for 30 daily packs).
• WW by the Vitamin Shoppe Daily Essentials + Heart Health: This daily pack combines the nutritional supplements in the Daily Essentials pack with alpha lipoic acid and ubiquinol to help support cardiovascular health ($46.99 for 30 daily packs).

In addition to the introduction of these new, co-branded nutritional supplements, people can now purchase a digital WW membership package at The Vitamin Shoppe and Super Supplements locations nationwide and on vitaminshoppe.com. This package includes a three-month digital membership to the myWW^Ⓡ+ program — WW’s most personalized program to-date – as well as the Starter Fee and a Starter Guide ($59.99; an $82.85 value if purchased separately). The myWW+ program offers a comprehensive approach to wellness that focuses on food, activity, mindset and sleep. Through a deeply enriching, more interactive and personalized app experience, the program is rooted in WW’s scientifically proven approach to weight loss and nutrition and grounded in the SmartPoints® system and ZeroPoint™ foods.

“Over the last year, the pandemic has elevated the need for the democratization and accessibility of wellness and, as a result, people are going through a reappraisal of how they live, how they work and what they value and want in their life,” said Mindy Grossman, President and CEO, WW International, Inc. “I’m thrilled to launch this new partnership with The Vitamin Shoppe because together, we can provide more resources to more people to empower them with sustainable, science-backed products and solutions to live their healthiest lives. With our combined communities and expert guidance and support, we can be the world’s partners in health.”

The Vitamin Shoppe and WW are founding members of the Healthy Living Coalition (HLC), an alliance of partners from private and non-profit sectors committed to action and solutions focused on improving food systems and helping close nutrition gaps that disproportionately impact underserved communities. 

For more information about The Vitamin Shoppe visit vitaminshoppe.com; and for more information on WW, visit ww.com.

About The Vitamin Shoppe®
The Vitamin Shoppe®, a subsidiary of Franchise Group Inc. (NASDAQ: FRG), is an omni-channel specialty retailer and wellness lifestyle Company with the mission of providing customers with the most trusted products, guidance, and services to help them become their best selves, however they define it. Based in Secaucus, New Jersey, the Company offers a comprehensive assortment of nutritional solutions, including vitamins, minerals, specialty supplements, herbs, sports nutrition, homeopathic remedies, green living products, and natural beauty aids. In addition to carrying products from approximately 700 national brands, The Vitamin Shoppe offers products from its proprietary brands within its owned and wholesale channels, including: The Vitamin Shoppe^®, Vthrive The Vitamin Shoppe™, BodyTech^®, BodyTech^® Elite, fitfactor Weight Management System™, fitfactor KETO™, plnt^®, ProBioCare^®, and True Athlete^®. The Company conducts business through over 715 company-operated retail stores under The Vitamin Shoppe and Super Supplements banners, and via its website, www.vitaminshoppe.com.

About WW International, Inc.
WW (formerly Weight Watchers) is a human-centric technology company powered by the world’s leading commercial weight management program. As a global wellness company, we inspire millions of people to adopt healthy habits for real life. Through our comprehensive digital app, expert Coaches and engaging experiences, members follow our proven, sustainable, science-based program focused on food, activity, mindset and sleep. Leveraging nearly six decades of expertise in nutritional and behavioral change science, providing real human connection and building inspired communities, our purpose is to democratize and deliver holistic wellness for all. To learn more about the WW approach to healthy living, please visit ww.com. For more information about our global business, visit our corporate website at corporate.ww.com. 

¹ Dietary Guidelines Advisory Committee. Scientific report of the 2020 dietary guidelines advisory committee: advisory report to the secretary of agriculture and the secretary of health and human Services. U.S. Department of Agriculture, Agricultural Research Service. 2020.

View original content to download multimedia:http://www.prnewswire.com/news-releases/the-vitamin-shoppe-and-ww-announce-strategic-partnership-to-support-healthy-living-301200823.html

SOURCE The Vitamin Shoppe

GERMANTOWN, Md., Jan. 5, 2021 /PRNewswire/ — Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, today announced that the US Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application to initiate a Phase I clinical trial of Precigen’s PRGN-2012, a first-in-class, investigational off-the-shelf (OTS) AdenoVerse^™ immunotherapy in adult patients with recurrent respiratory papillomatosis (RRP). RRP is a rare, difficult-to-treat and sometimes fatal neoplastic disease of the upper and lower respiratory tracts caused by human papillomavirus (HPV) type 6 (HPV 6) or HPV type 11 (HPV 11).^1-4  

PRGN-2012 is an innovative therapeutic vaccine with optimized antigen design that uses Precigen’s gorilla adenovector technology, part of Precigen’s proprietary AdenoVerse platform, to elicit immune responses directed against cells infected with HPV 6 or HPV 11.  Gorilla adenovectors have numerous advantages, including the ability for repeat administration, the inability to replicate in vivo, which may improve safety, and the ability to deliver large payload capacity. In preclinical models, PRGN-2012 has demonstrated strong and specific immune response against HPV 6 and HPV 11.

The Phase I study will follow 3+3 dose escalation of PRGN-2012 as an adjuvant immunotherapy following standard-of-care surgical removal of visible papillomatosis disease. Patients will receive up to four injections of PRGN-2012. The primary objective of the study is to determine safety and tolerability and recommended Phase II dose (RP2D) of PRGN-2012. The study will enroll 3 to 6 subjects at each dose level, and 12 patients will be treated at the maximum tolerated dose.

PRGN-2012 is under development through a Cooperative Research and Development Agreement, or CRADA, with the Center for Cancer Research (CCR) at the National Cancer Institute (NCI). This CRADA has allowed Precigen to rapidly and cost-effectively advance PRGN-2012 to the clinic. The Phase I clinical study of PRGN-2012 will be led by Clint T. Allen, MD, Principal Investigator, Section on Translational Tumor Immunology, of the National Institute on Deafness and Other Communication Disorders (NIDCD), and Scott M. Norberg, DO, Assistant Research Physician, Genitourinary Malignancies Branch, of CCR NCI. 

“For patients with RRP there is an urgent need for adjuvant treatment options to reduce the number of devastating repeat surgical procedures to remove papillomatous lesions,” said Helen Sabzevari, PhD, President and CEO of Precigen. “This is our second AdenoVerse immunotherapy IND in collaboration with NCI and is a testament to our strong, collaborative relationship and our ability to work together to quickly advance promising assets where there is high unmet patient need.” 

###

About
Recurrent Respiratory Papillomatosis (
RRP)
Recurrent respiratory papillomatosis (RRP) is a rare, difficult-to-treat and sometimes fatal neoplastic disease of the upper and lower respiratory tracts that is caused by infection with HPV 6 or HPV 11.^1-4 RRP is classified based on age of onset as juvenile or adult. Juvenile-onset disease has an incidence of 4 per 100,000 and adult-onset RRP has an incidence of 2 to 3 per 100,000. There is no cure for RRP and  the current standard-of-care is repeated endoscopic debulking with ablation or excision of papillomatous lesions.^3,4 Recurrence of papilloma after surgical removal is very common and repeated procedures are required to debulk and monitor the disease, which exposes patients to anesthetic and surgical risks, and emotional distress. RRP morbidity and mortality results from the effects of papilloma mass on the vocal cords, trachea, and lungs, which may cause voice changes, stridor, airway occlusion, loss of lung volume, and/or post-obstructive pneumonia.⁵ Although rare, one to three percent of RRP cases can transform into invasive squamous cell carcinoma.^6,7

Precigen: Advancing Medicine with Precision^™
Precigen (Nasdaq: PGEN) is a dedicated discovery and clinical stage biopharmaceutical company advancing the next generation of gene and cell therapies using precision technology to target the most urgent and intractable diseases in our core therapeutic areas of immuno-oncology, autoimmune disorders, and infectious diseases. Our technologies enable us to find innovative solutions for affordable biotherapeutics in a controlled manner. Precigen operates as an innovation engine progressing a preclinical and clinical pipeline of well-differentiated unique therapies toward clinical proof-of-concept and commercialization. For more information about Precigen, visit www.precigen.com or follow us on Twitter @Precigen and LinkedIn.

Trademarks
Precigen, AdenoVerse and Advancing Medicine with Precision are trademarks of Precigen and/or its affiliates. Other names may be trademarks of their respective owners.

Cautionary Statement Regarding Forward-Looking Statements
Some of the statements made in this press release are forward-looking statements. These forward-looking statements are based upon the Company’s current expectations and projections about future events and generally relate to plans, objectives, and expectations for the development of the Company’s business, including the timing and progress of preclinical studies, clinical trials, discovery programs and related milestones, the promise of the Company’s portfolio of therapies, and in particular its CAR-T therapies, and the Company’s refocus to a healthcare-oriented business. Although management believes that the plans and objectives reflected in or suggested by these forward-looking statements are reasonable, all forward-looking statements involve risks and uncertainties, including the possibility that the timeline for the Company’s clinical trials might be impacted by the COVID-19 pandemic, and actual future results may be materially different from the plans, objectives and expectations expressed in this press release. The Company has no obligation to provide any updates to these forward-looking statements even if its expectations change. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. For further information on potential risks and uncertainties, and other important factors, any of which could cause the Company’s actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and subsequent reports filed with the Securities and Exchange Commission.

References

¹ Mounts, P et al. (1982). “Viral etiology of juvenile- and adult-onset squamous papilloma of the larynx.” Proc Natl Acad Sci U S A 79(17): 5425-5429.
² Smith, E et al. (1993). “Human papillomavirus infection in papillomas and nondiseased respiratory sites of patients with recurrent respiratory papillomatosis using the polymerase chain reaction.” Arch Otolaryngol Head Neck Surg 119(5): 554-557.
³ Derkay, CS et al. (2008). “Recurrent respiratory papillomatosis: a review.” Laryngoscope 118(7): 1236-1247.
⁴ Derkay, CS et al. (2019). “Update on Recurrent Respiratory Papillomatosis.” Otolaryngol Clin North Am 52(4): 669-679.
⁵ Seedat, RY (2020). “Juvenile-Onset Recurrent Respiratory Papillomatosis Diagnosis and Management – A Developing Country Review.” Pediatric Health Med Ther 11: 39-46.
⁶ Dedo, HH et al. (2001). “CO(2) laser treatment in 244 patients with respiratory papillomas.” Laryngoscope 111(9): 1639-1644.
⁷ Silver, RD et al. (2003). “Diagnosis and management of pulmonary metastasis from recurrent respiratory papillomatosis.” Otolaryngol Head Neck Surg 129(6): 622-629.

For more information, contact:

View original content to download multimedia:http://www.prnewswire.com/news-releases/precigen-announces-clearance-of-ind-to-initiate-phase-i-study-of-prgn-2012-adenoverse-immunotherapy-in-patients-with-recurrent-respiratory-papillomatosis-rrp-301200592.html

SOURCE Precigen, Inc.

LAKE SUCCESS, N.Y., Jan. 5, 2021 /PRNewswire/ — The Hain Celestial Group, Inc. (Nasdaq: HAIN) (“Hain Celestial”, “Hain” or the “Company”), a leading organic and natural products company with operations in North America, Europe, Asia and the Middle East providing consumers with A Healthier Way of Life™, today announced that the Company is hosting a fireside chat discussion at the 2021 ICR Conference on Wednesday, January 13, 2021 at 11:30 AM Eastern Time. The webcast can be accessed on Hain Celestial’s website at www.hain.com under Investor Relations and the Press & Events section.

About The Hain Celestial Group, Inc.
The Hain Celestial Group (Nasdaq: HAIN), headquartered in Lake Success, NY, is a leading organic and natural products company with operations in North America, Europe, Asia and the Middle East. Hain Celestial participates in many natural categories with well-known brands that include Celestial Seasonings®, Clarks™, Cully & Sully®, Dream®, Earth’s Best®, Ella’s Kitchen®, Farmhouse Fare™, Frank Cooper’s®, GG UniqueFiber®, Gale’s®, Garden of Eatin’®, Hain Pure Foods®, Hartley’s®, Health Valley®, Imagine®, Joya®, Lima®, Linda McCartney® (under license), MaraNatha®, Natumi®, New Covent Garden Soup Co.®, Orchard House®, Robertson’s®, Sensible Portions®, Spectrum®, Sun-Pat®, Sunripe®, Terra®, The Greek Gods®, William’s™, Yorkshire Provender® and Yves Veggie Cuisine®. The Company’s personal care products are marketed under the Alba Botanica®, Avalon Organics®, Earth’s Best®, JASON®, Live Clean®, One Step® and Queen Helene® brands.

View original content to download multimedia:http://www.prnewswire.com/news-releases/hain-celestial-to-participate-in-the-2021-icr-conference-301200815.html

SOURCE The Hain Celestial Group, Inc.